AbbVie Senior QC Lab Analyst/Instrumentation Specialist in Sligo, Ireland
Senior QC Lab Analyst/Instrumentation Specialist
Ireland, Connaught, Sligo
2 additional locations
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We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be the No.1 Best Place to Work in Ireland!
We are currently sourcing a Senior QC Lab Analyst/ Instrumentation Specialist to join our high performing quality team. In this role, you will ensure all laboratory instrumentation and equipment is operating, maintained and serviced as per schedule ensuring that products manufactured are tested to specification on time and quality and safety goals are met.
Ensure Laboratory Computerized Systems compliance with Data Integrity policies and regulatory requirements.
Understand Regulations and business processes required to maintain Laboratory Data Integrity.
Ensuring all lab equipment is calibrated, qualified and maintained, adhering to schedules.
Preparation and Review of documentation, pre and post approvals.
Liasing and working with external vendors.
Management of the Maximo system for laboratory equipment.
Sourcing of new equipment through the Change plan process.
Ensuring Laboratory operational efficiency by participating in project teams assigned by the Quality Control Manager.
Control and management of laboratory purchasing/VMI related to instruments and equipment.
Working closely with the QC Laboratory to ensure activities are planned and executed safely and efficiently.
Management of MEP in the QC Laboratory.
Education & Experience:
Relevant 3rd level degree
A minimum of three years experience in the pharmaceutical industry .
Experience in QC testing in an HPRA/FDA regulated laboratory
Laboratory equipment maintenance experience is desirable
Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
Proven track record of project planning / maintenance planning